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Title: Evaluating the Time Toxicity of Cancer Treatment in the CCTG CO.17 Trial.
Austin Authors: Gupta, Arjun;O'Callaghan, Christopher J ;Zhu, Liting;Jonker, Derek J;Wong, Ralph P W;Colwell, Bruce;Moore, Malcolm J;Karapetis, Christos S;Tebbutt, Niall C ;Shapiro, Jeremy D;Tu, Dongsheng;Booth, Christopher M
Affiliation: University of Minnesota, Minneapolis, MN.
Canadian Cancer Trials Group, Kingston, ON, Canada.
Canadian Cancer Trials Group, Kingston, ON, Canada.
The Ottawa Hospital Cancer Centre, ON, Canada.
CancerCare Manitoba, Winnipeg, MB, Canada.
Dalhousie University, Halifax, NS, Canada.
Princess Margaret Cancer Centre, Toronto, ON, Canada.
Flinders University, Adelaide, SA, Australia.
Austin Health
Cabrini Health, Malvern, VIC, Australia.
Canadian Cancer Trials Group, Kingston, ON, Canada.
Department of Oncology, Queen's University, Kingston, ON, Canada.
Issue Date: 7-Mar-2023 2023
Publication information: JCO Oncology Practice 2023; online first: 7 March
Abstract: The time spent in pursuing treatments for advanced cancer can be substantial. We have previously proposed a pragmatic and patient-centered metric of these time costs-which we term time toxicity-as any day with physical health care system contact. This includes outpatient visits (eg, bloodwork, scans, etc), emergency department visits, and overnight stays in a health care facility. Herein, we sought to assess time toxicity in a completed randomized controlled trial (RCT). We conducted a secondary analysis of the Canadian Cancer Trials Group CO.17 RCT that evaluated weekly cetuximab infusions versus supportive care alone in 572 patients with advanced colorectal cancer. Initial results reported a 6-week improvement in median overall survival (OS) with cetuximab (6.1 v 4.6 months). Subsequent analyses reported that benefit was restricted to patients with K-ras wild-type tumors. We calculated patient-level time toxicity by analyzing trial forms. We considered days without health care contact as home days. We compared medians of time measures across arms and stratified results by K-ras status. In the overall population, median time toxic days were higher in the cetuximab arm (28 v 10, P < .001) although median home days were not statistically different between arms (140 v 121, P = .09). In patients with K-ras-mutated tumors, cetuximab was associated with almost numerically equal home days (114 days v 112 days, P = .571) and higher time toxicity (23 days v 11 days, P < .001). In patients with K-ras wild-type tumors, cetuximab was associated with more home days (186 v 132, P < .001). This proof-of-concept feasibility study demonstrates that measures of time toxicity can be extracted through secondary analyses of RCTs. In CO.17, despite an overall OS benefit with cetuximab, home days were statistically similar across arms. Such data can supplement traditional survival end points in RCTs. Further work should refine and validate the measure prospectively.
DOI: 10.1200/OP.22.00737
ORCID: 0000-0003-0875-4731
Journal: JCO Oncology Practice
Start page: OP2200737
PubMed URL: 36881786
ISSN: 2688-1535
Type: Journal Article
Appears in Collections:Journal articles

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